Silymarin Supplement Tested in Kidney Transplant Recipients Early After Surgery
Tests silymarin against placebo in kidney transplant patients, checking graft function and complications.
Plain-language title generated from the registry record
Registry title: Silymarin's Advantage on Graft Effectiveness
Key facts
- Where
- Martin, SlovakiaSee the site
- Phase
- Phase 3
Where in Slovakia
- University Hospital MartinMartin, SlovakiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Martin
- Trial code
- NCT06801886
- Record updated
- 30 March 2025
- Original description
The study examines the impact of silymarin supplementation during the early post-transplant period, administering 900 g daily for 30 days under standard treatment. Subsequently, the investigators investigate its impact on graft function, as measured by eGFR (CKD-EPI equation), UACR or UPCR, the development of dnDSA, rejection changes, and histological changes in the 3-month biopsy protocol. At the same time, investigators will investigate the effect of silymarin on metabolic complications-PTDM, DLP, disorders of calcium-phosphate metabolism, and arterial hypertension in the post-transplant period-in comparison with the placebo group. At the same time, investigators will investigate the safety and tolerance of silymarin.Read full original descriptionShow less
Effect of Silymarin Supplementation on Graft Function and Early Post-transplant Complications
The study examines the impact of silymarin supplementation during the early post-transplant period, administering 900 g daily for 30 days under standard treatment. Subsequently, the investigators investigate its impact on graft function, as measured by eGFR (CKD-EPI equation), UACR or UPCR, the development of dnDSA, rejection changes, and histological changes in the 3-month biopsy protocol. At the same time, investigators will investigate the effect of silymarin on metabolic complications-PTDM, DLP, disorders of calcium-phosphate metabolism, and arterial hypertension in the post-transplant period-in comparison with the placebo group. At the same time, investigators will investigate the safety and tolerance of silymarin.
Inclusion: First or second kidney transplant recipient; Deceased or living donor kidney transplant; Patients receiving standard immunosuppression regimen:; Tacrolimus or cyclosporine + Mycophenolate mofetil + Corticosteroids; Body Mass Index (BMI) 18-35 kg/m²; Willingness to provide informed consent; Ability to understand and comply with study procedures; Stable medical condition without significant comorbidities.
Exclusion: Multi-organ transplant recipients; Patients taking medications with significant interactions with silymarin:; Anticoagulants, Cytochrome P450 enzyme modulators; Active infectious complications at the time of transplantation: HIV, Active hepatitis B or C, Active cytomegalovirus (CMV) infection; Significant cardiovascular disease: Recent myocardial infarction (within 6 months), Unstable angina, Severe heart failure (NYHA Class III or IV); Malignancy within the past 5 years (except successfully treated non-melanoma skin cancer); Known allergy or hypersensitivity to silymarin or milk thistle; Psychiatric conditions that may interfere with study compliance; History of non-compliance with medical treatment; Patients with known genetic disorders affecting drug metabolism; Patients with known liver disease: Cirrhosis, Active hepatitis, ALT or AST > 2.5 times the upper limit of normal; Uncontrolled diabetes mellitus (HbA1c > 8.5%); Recipients of ABO-incompatible or highly sensitized transplants; Current or recent (within 30 days) participation in another clinical trial; Pregnancy or planned pregnancy during the study period.